Medical Device Regulatory Glossary
Comprehensive definitions for medical device regulatory terminology. Learn what FDA 510(k), CE Marking, EU MDR, ANVISA, NMPA, and other regulatory terms mean.
What is a medical device regulatory glossary?
A medical device regulatory glossary is a reference guide that defines terminology used in the medical device industry. It covers regulatory authorities (FDA, ANVISA, NMPA), submission types (510(k), PMA, De Novo), compliance standards (CE Marking, GMP, ISO 13485), and market access requirements across global markets.
About This Medical Device Regulatory Glossary
This glossary provides clear, accurate definitions of medical device regulatory terminology used by regulatory affairs professionals, quality managers, and industry stakeholders worldwide. Whether you're navigating FDA submissions, EU MDR compliance, or expanding into markets like Brazil, China, or Japan, understanding regulatory terminology is essential for success.
Key Topics Covered
Regulatory Authorities
FDA, ANVISA, NMPA, PMDA, COFEPRIS, and more
Global Market Access
CE Marking, 510(k), PMA, registration pathways
This resource is part of Pure Global's "FREE AI for Global Good" initiative, providing free regulatory intelligence to help medical device companies bring life-saving technologies to patients worldwide.
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